Implant FAQ

Yes, the implants can be saved. If the implant pockets are soft, then this would be very reasonable. If the implants are of the textured variety, I would replace them with a smooth implant due to the association of textured implants with Breast Implant Associated-Anaplastic Large Cell Lymphoma (BIA-ALCL). Hope this helps, Good luck!

You have significant breast ptosis or low nipples as well as significant breast asymmetry and volume discrepancy. You are wise to be concerned about above the muscle and capsule formation. I have a few questions. What are your goals? What size breasts do you want? IMHO performing a breast lift and making you breasts a more youthful and symmetric size is what I would offer you as an initial procedure. If you are happy then fantastic. If at 3 months you really want larger breasts then we place a saline or silicone sub muscular implant which will have a significantly lower rate of CC and be more stable over time. You could do both procedures at once but a higher risk of complications and need for a revision surgery. Good Luck and update us on your decision.

Size is hard to predict but a 300cc moderate plus saline implant should be a C cup for you. I prefer the armpit incision for saline implants as no viable breast scar. I do think the surgery is best performed with an endoscope for precise dissection and control of bleeding. I hope this helps good luck!

Yes, you can do this. It is an advanced procedure which IMHO should be done with an endoscope not a blind seep. Several Scandinavian countries have good study results doing this procedure. The implant size will dictate the incision length to some extent. Good Luck!

Size is important but also the shape or profile of the implant. A 12 cm base width with a moderate profile will be about 300cc which is about a 2 full cup size increase in breast size. I think 230 cc seems small. Evaluate lots of before and after pictures that look like you. You are researching things well and please update us on your choice. Good Luck!

Additional questions about other types of surgeries and Dr. Lynam’s responses can be found here:

Statement from Binita Ashar, M.D., of the FDA’s Center for Devices and Radiological Health on agency’s continuing efforts to educate patients on known risk of lymphoma from breast implants:

“…Today, the agency is providing an updated number of medical device reports (MDRs), also known as adverse event reports. After a thorough data analysis, we are reporting that, as of September 2018, the agency has received a total of 660 total medical device reports regarding BIA-ALCL cases since 2010. Of the 660 MDRs, our in-depth analysis suggests that there are 457 unique cases of BIA-ALCL, including 9 patient deaths.

We understand that the information presented shows an increase of 246 new MDRs since last year. Given the agency’s continued efforts to communicate with stakeholders about BIA-ALCL risks and our work to encourage patients and providers to file MDRs with the agency, these types of increases in the MDRs are to be expected and may include past cases that were not previously reported to the FDA. The increased number of MDRs contributes to our evolving understanding of BIA-ALCL and represents a more thorough and comprehensive analysis…”

From The Independent:

“A type of cancer linked to breast implants has been diagnosed in more women, according to a statement from the Food and Drug Administration (FDA)… Nine women have died from the rare cancer that affects the immune system, a known risk from breast implants that was first reported by the FDA in 2011.

While the slow-growing lymphoma is not breast cancer, it is found around breast implants. Health officials also explained the lymphoma is more likely to occur in women who have implants with a textured coating rather than a smooth coating. Textured implants, which have a rougher outer layer meant to adhere to tissue surrounding them, are typically used in cases where the patient and surgeon do not want the implant to move around within the breast pocket.

https://www.independent.co.uk/news/world/americas/breast-implants-cancer-risk-fda-lymphoma-lift-texture-chemotherapy-radiation-a8768231.html

Penn State article:

In a Penn State news article dated 10/18/2018 and entitled Rare Cancer Linked with Breast Implants may be Underreported, Misunderstood, reporter Katie Bohn writes, ” A rare cancer in patients with breast implants may be on the rise, but not all patients and physicians may be aware of the risks associated with the procedure, according to a group of Penn State College of Medicine researchers…We’re seeing that this cancer is likely very underreported, and as more information on this type of cancer comes to light, the number of cases is likely to increase in the coming years,” said Dino Ravnic, assistant professor of surgery, Penn State College of Medicine. “We’re still exploring the exact causes, but according to current knowledge, this cancer only really started to appear after textured implants came on the market in the 1990s…” The full article can be read here: https://news.psu.edu/story/488829/2017/10/18/research/rare-cancer-linked-breast-implants-may-be-underreported

NBC News Investigation: Textured Breast Implants

According to NBC News, “When Michelle Forney’s breast started swelling and itching, doctors told her she had mastitis, a common infection, and treated her with antibiotics. When she discovered that she, in fact, had a rare form of lymphoma and that it was probably caused by her breast implant, she was both furious and frightened. Forney is just one of hundreds of breast-implant recipients who have developed a rare blood cancer called anaplastic large cell lymphoma (ALCL). The Food and Drug Administration has been investigating reports linking breast implants with the cancer, and now has more than 400 reports about patients who developed ALCL after having a breast implant, including nine who died…”

The full article and video can be found here:https://www.nbcnews.com/nightly-news/video/doctors-patients-raise-alarms-about-cancer-linked-to-breast-implants-1381021763837 and https://www.nbcnews.com/health/health-news/fda-affirms-breast-implants-can-cause-rare-form-cancer-n736551?icid=related

The Guardian:

“A type of breast implant used by millions of women around the world is under scrutiny after French surgeons were advised to stop using it because of a potential link with a rare kind of cancer.

Textured breast implants have been linked with anaplastic large cell lymphoma (ALCL), which forms in the scar capsule around the implant and normally begins with pain and swelling in the breast.

Women who have the implants and capsules removed can make a full recovery, but if left untreated the disease can spread throughout the body and become life-threatening…”

https://www.theguardian.com/society/2018/nov/26/rare-cancer-linked-breast-implant-used-by-millions-women-lymphoma

Fortune:

“France’s national health regulator refused to renew approval Tuesday for two types of Allergan textured breast implants. That means Allergan cannot sell its Microcell and Biocell textured breast implants in Europe.

The agency advises patients with the implants to undergo regular checks with their doctors for a blood cancer called anaplastic large cell lymphoma (ALCL), which occurs more often in women with textured breast implants. Plastic surgeons have identified more than 600 cases worldwide. ALCL is treatable.

The U.S. Food and Drugs Administration permits the sale of such implants despite knowing since 2011 about the increased risk. Last week the agency agreed to hold a meeting of medical advisors in 2019 to address concerns.

In November, the International Consortium of Investigative Journalists reported on the lack of transparency and rigor in government oversight of medical devices. U.S. figures alone revealed an average of 8,000 deaths a year linked to medical devices. The breast implant cases were one of those highlighted in the reporting.

The Guardian estimates that the medical technology market in Europe is worth around $125 billion a year, so regulators are up against a lot of economic heft.

Worried about your own implant? The ICIJ has built a database noting more than 70,000 recalls, safety alerts, and other device-related medical notices.

http://fortune.com/2018/12/19/europe-bans-allergan-breast-implants/.

ICIJ database: https://medicaldevices.icij.org/

European Recall in US News Regarding Textured Implants

USA Today reported, “Biopharmaceutical company Allergan is recalling rough-surface breast implants in Europe. The company said its breast implants are safe and it’s not recommending surgical removal, which can cause health problems. But it will no longer offer the “textured” version in Europe.

Smooth implants will be sold there.

The move comes after a French regulatory agency asked the company to take action after the textured produce lost its CE Mark health-and-safety certification. Some researchers have raised concerns about a cancer risk connected to certain textured implants…”

The full article can be found here: https://www.usatoday.com/story/money/2018/12/19/allergan-textured-breast-implant-recall/2360954002/

In Global Healthcare Knowledge Provider Journal, BMJ:

One of the world’s best-selling types of silicone breast implants, which have been linked to a rare form of atypical lymphoma (BIA-ALCL), have been removed from the market across Europe.The recall of Allergan textured implants came after the French national agency for the safety of medicines and health products (ANSM) said it was suspending the ConformiteEuropeene (CE) mark for Allergan’s Microcell and Biocell products. It means that, for now, the implants cannot be manufactured or sold in Europe and those held at clinics are being recalled.

https://www.bmj.com/content/363/bmj.k5401.full

Not at this time. In 2019, the FDA will convene a meeting of the General and Plastic Surgery Devices Panel at the FDA’s Headquarters in Silver Spring, Maryland, to discuss a range of topics concerning the benefit-risk profile of breast implants. The FDA plans to publish a Federal Register notice and agenda on the FDA’s Advisory Committee Calendar webpage 15 days in advance of the meeting. You can also sign up to receive email updates about all FDA advisory committee meetings. For more information or to sign up for updates:
https://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/BreastImplants/default.htm

FDA research and ALCL:

Since 2016, there have been several advances in the description of the disease and treatment recommendations. These are summarized below:The World Health Organization recognized breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) as a unique form of ALCL that can develop following breast implant, implantation. Per the 2016 Revision of the World Health Organization classification of lymphoid Neoplasms, “A number of studies in recent years have identified a unique form of ALK− ALCL arising in association with breast implants designated as breast implant–associated ALCL. First described in 1997, it usually presents as an accumulation of seroma fluid between the implant itself and the surrounding fibrous capsule. Both saline- and silicone-filled implants have been implicated, with a median interval from the time of the implant to the lymphoma of about 10 years. In most cases, the neoplastic cells are confined to the seroma fluid, without invasion of the capsule. In such cases, conservative management is recommended, with removal of the implant and capsule. If there is invasion through the capsule, there is risk of lymph node involvement and systemic spread, warranting systemic chemotherapy. The factors leading to progression have not been delineated.
http://www.bloodjournal.org/content/127/20/2375?sso-checked=true

Professional organizations including the Plastic Surgery Foundation and the National Comprehensive Cancer Network (NCCN) published information to help physicians understand the disease and provide diagnosis and treatment. Per the Plastic Surgery Foundation website, “ASPS/PSF and FDA are collaborating to conduct research and develop a Breast Implant-Associated ALCL Registry, the PROFILE Registry, to increase the scientific data on ALCL in women with breast implants. The collaboration involves the development of PROFILE and in the proposed research to characterize ALCL in women with breast implants. The Plastic Surgery Foundation website can be found here: https://www.thepsf.org/research/registries/profile.

FDA Warningregarding breast implants:

In January 2011, the FDA issued a Safety Communication on anaplastic large cell lymphoma (ALCL) in women with breast implants. Based on a review of the scientific literature, the FDA believes that women with breast implants may have a very small but increased risk of developing this disease in the scar capsule adjacent to the implant. According to the Executive Summary of the report, “Although ALCL is extremely rare, the FDA believes that women with breast implants may have a very small but increased risk of developing this disease in the scar capsule adjacent to the implant. Based on available information, it is not possible to confirm with statistical certainty that breast implants cause ALCL. At this time, data appear to indicate that the incidence of ALCL is very low, even in breast implant patients. Currently it is not possible to identify a type of implant (silicone versus saline) or a reason for implant (reconstruction versus aesthetic augmentation) associated with a smaller or greater risk.”

The 2011 FDA recommendations include, “Consider the possibility of ALCL when you have a patient with late onset, persistent peri-implant seroma. In some cases, patients presented with capsular contracture or masses adjacent to the breast implant. If you have a patient with suspected ALCL, refer her to an appropriate specialist for evaluation. When testing for ALCL, collect fresh seroma fluid and representative portions of the capsule and send for pathology tests to rule out ALCL. Diagnostic evaluation should include cytological evaluation of seroma fluid with Wright Giemsa stained smears and cell block immunohistochemistry testing for cluster of differentiation (CD) and Anaplastic Lymphoma Kinase (ALK) markers.

Report all confirmed cases ALCL in women with breast implant to the FDA. In some cases, the FDA may contact you for additional information. The FDA will keep the reporter’s and the patient’s identity confidential.

Develop an individualized treatment plan in coordination with the patient’s multi-disciplinary care team. Because of the small number of cases worldwide and variety of available treatment options, there is no single defined consensus treatment regimen.

More information can be found here: http://wayback.archive-it.org/7993/20171115053750/https:/www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/BreastImplants/ucm239996.htm

Recommendations regarding breast implants:

The FDA does not recommend prophylactic breast implant removal in patients without symptoms or other abnormalities.

The FDA doesrecommend: Educate yourself about breast implants before agreeing to surgery. Breast implants approved in the U.S. can be filled with either saline or with silicone gel. They come in different sizes and shapes and have either smooth or textured surfaces (shells).

Additional information is available on the FDA’s Breast Implants website: https://www.fda.gov/medicaldevices/productsandmedicalprocedures/implantsandprosthetics/breastimplants/default.htm. Per the FDA, BIA-ALCL appears to develop more frequently in individuals with textured implants than in people with smooth-surfaced implants. Before getting breast implants, make sure to talk to your health care provider about the benefits and risks of both textured-surface and smooth-surfaced implants.

If you have breast implants, there is no need to change your routine medical care and follow-up. You should expect swelling and pain immediately after surgery. If you notice changes in the way your breast looks or feels after you recover from surgery—including swelling or pain around the implant—be sure to talk to your health care provider about the possibility of BIA-ALCL.

Although not specific to BIA-ALCL, you should follow standard medical recommendations including:
• Follow your doctor’s instructions on how to monitor your breast implants. If you notice any changes, contact your health care provider promptly to schedule an appointment.

• Follow your doctor’s instructions for routine mammography screening. Be sure to inform the mammography facility that you have breast implants so enough time is scheduled for your mammogram. Your doctor may also recommend other tests, such as magnetic resonance imaging (MRI).

More information can be found here: https://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/BreastImplants/ucm239995.htm

A rare subtype of ALCL has been identified in women who have textured silicone breast implants (protheses). This is known as breast implant associated anaplastic large cell lymphoma, or BIA-ALCL. It can occur as a result of breast reconstruction after a diagnosis of breast cancer or as a result of cosmetic surgery using textured silicone implants. BIA-ALCL initially occurs in the fluid contained within the scar capsule surrounding the implant, rather than the breast tissue itself. The tumor initially manifests with swelling of the breast due to fluid accumulation around the implant. The disease may progress to invade the tissue surrounding the capsule, and if left untreated may progress to the axillary lymph nodes.It typically presents at a late stage and is often associated with systemic symptoms.
https://en.wikipedia.org/wiki/Anaplastic_large-cell_lymphoma

In 2011, the FDA identified a possible association between breast implants and the development of anaplastic large cell lymphoma (ALCL).Although ALCL is extremely rare, the FDA believes that women with breast implants have a risk of developing breast implant-associated anaplastic large cell lymphoma, or BIA-ALCL. BIA-ALCL is not breast cancer—it is a type of non-Hodgkin’s lymphoma (cancer of the immune system). In most cases, BIA-ALCL is found in the scar tissue and fluid near the implant, but in some cases, it can spread throughout the body. According to the World Health Organization, BIA-ALCL is a T-cell lymphoma that can develop following breast implants. Anaplastic Large Cell Lymphoma is a type of non-Hodgkin’s lymphoma, a cancer of the cells of the immune system. It can occur in many different parts of the body, including the lymph nodes and skin. Even though BIA-ALCL is found in the breasts of some individuals (cis- and trans-gender women and men) with breast implants, it is not breast cancer.
http://wayback.archive-it.org/7993/20171115053750/https://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/BreastImplants/ucm239996.htm

In 2017, the U.S. Food and Drug Administration (FDA) updated its 2011 warning about a link between breast implants and a very rare form of cancer: anaplastic large-cell lymphoma. Because the cancer is linked to breast implants, the FDA calls the cancer breast implant-associated anaplastic large-cell lymphoma (BIA-ALCL).If BIA-ALCL develops after a breast implant is placed, the lymphoma is almost always only in the capsule of scar tissue that forms around the implant. So, the BIA-ALCL usually can be successfully treated by removing the implant and the scar tissue capsule. Additional treatments such as radiation therapy and chemotherapy usually aren’t needed but may be recommended in some cases.While the exact number of cases of BIA-ALCL has been difficult to figure out because of limited worldwide reporting, the FDA did say that it had received 359 reports of the cancer and that nine women had died from the disease.

The risk of BIA-ALCL is higher in women who have textured implants, which have a bumpy surface, as opposed to smooth implants, according to the FDA.Doctors estimate that anaplastic large-cell lymphoma is diagnosed in one of every 500,000 women, making it very uncommon. Anaplastic large-cell lymphoma can develop in other places in the body besides the breast. A BIA-ALCL diagnosis is quite rare: out of 100 million women, it’s estimated that only 3 cases would be diagnosed in a year.Most of the women who were diagnosed went to their doctors and were diagnosed with BIA-ALCL because fluid had collected around the implant (called a seroma) YEARS after the implant was placed. In some cases, testing the seroma fluid led to the diagnosis. In other cases, BIA-ALCL was diagnosed after a mass was found in the breast or because the tissue capsule tightened (called capsular contracture) and caused discomfort or cosmetic problems.

If you have an implant, the FDA recommends:
• regular monitoring for symptoms of BIA-ALCL
• if you have no symptoms of BIA-ALCL, there is no need to remove the implant and no need to change your routine medical care and follow up
https://www.breastcancer.org/research-news/study-estimates-risk-of-rare-cancer-from-implants

A form of ALCL is associated with implants. Textured breast implants are most commonly identified and have been the focus of research, but tibial implants, dental implants, injection port implants, gluteal implants, and gastric band placement have also been reported. Risk is highest with most strongly textured implants.Chronic inflammation is known to lead to lymphoma. It has been suggested that inflammation surrounding textured implants causes proliferation and activation of T-cells.
https://en.wikipedia.org/wiki/Anaplastic_large-cell_lymphoma

Per the FDA, there is a possible association between breast implants and ALCL. Based on available data, the incidence of ALCL, even in breast implant patients, appears to be very low. However, despite the low total number of reported cases, certain factors suggest the occurrence of ALCL in patients with breast implants may not be coincidence. If ALCL in women with breast implants were due only to chance, one would expect for it to occur with similar frequency in all parts of the breast. Instead, ALCL is usually located in the region immediately surrounding the breast implant. Furthermore, the vast majority of primary breast lymphomas reported in patients without breast implants are of the B-cell phenotype. In contrast, ALCL is a T-cell lymphoma, suggesting the observation may be more than chance.
http://wayback.archive-it.org/7993/20171115053750/https://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/BreastImplants/ucm239996.htm

The type of implant fill does not appear to be a risk factor for BIA-ALCL.
https://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/BreastImplants/ucm241086.htm

If BIA-ALCL develops after a breast implant is placed, the lymphoma is almost always only in the capsule of scar tissue that forms around the implant. So, the BIA-ALCL usually can be successfully treated by removing the implant and the scar tissue capsule. Additional treatments such as radiation therapy and chemotherapy usually aren’t needed but may be recommended in some cases. https://www.breastcancer.org/research-news/fda-updates-on-textured-implants-and-cancer

BIA-ALCL is usually found near the breast implant, contained within the fibrous scar capsule, and not in the breast tissue itself. In most cases, the ALCL cells were found in the fluid surrounding the implant (seroma) or contained within the fibrous scar capsule.
https://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/BreastImplants/ucm241086.htm

The main symptoms of BIA-ALCL are persistent swelling or pain in the vicinity of the breast implant. These symptoms may occur well after the surgical incision has healed, often years after implant placement. Upon evaluation by a health care provider, evidence of fluid collection around the breast implant (seroma) is often observed. Some patient reports indicated that a lump under the skin or capsular contracture (thick and noticeable scar capsule around the implant) were present.

ALCL is characterized by abnormal growth of T-lymphocytes (T-cells) and strong expression of a protein, cytokine receptor CD30. ALCL can involve many parts of the body, including the lymph nodes and skin. There are currently two major variants of ALCL recognized in the literature, one of which expresses the protein anaplastic lymphoma kinase (ALK-positive) and a second which does not (ALK-negative).

According to the FDA, precise risks are difficult to determine due to lack of information about how many patients have received breast implants in the US and worldwide.Over time, the FDA has strengthened their understanding of this condition. In 2016, the World Health Organization designated breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) as a T-cell lymphoma that can develop following breast implants. The exact number of cases remains difficult to determine due to significant limitations in world-wide reporting and lack of global breast implant sales data. At this time, most data suggest that BIA-ALCL occurs more frequently following implantation of breast implants with textured surfaces rather than those with smooth surfaces.

Diagnosis

The diagnosis of ALCL requires the examination by a pathologist of any enlarged lymph node, or any affected extranodal tissue where there the tumor is found, such as the intestine, the liver or bone in the case of systemic ALCL. For the case of cutaneous ALCL, a skin excision is recommended, and for the diagnosis of ALCL associated with breast implants, a cytologic specimen of the effusion around the breast implant or complete examination of the breast capsule surrounding the implant is required. https://en.wikipedia.org/wiki/Anaplastic_large-cell_lymphoma

Prognosis

According to the American Society of Plastic Surgery:
Breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) is a rare and highly treatable type of lymphoma that can develop around breast implants. BIA-ALCL occurs most frequently in patients who have breast implants with textured surfaces…Since the initial case report in 1996, ASPS now recognize approximately 265 cases in the US and a total of 673 worldwide as of January 25, 2019.

Most of the patients who have developed BIA-ALCL receive an excellent prognosis following surgical removal of the breast implants and the surrounding scar tissue capsule. Continued follow-up after any breast implant surgery is suggested and important for patient health, but patients who notice pain, lumps, swelling, fluid collections or unexpected changes in breast shape, including asymmetry, should contact their plastic surgeon. In most cases, women diagnosed with BIA-ALCL observed changes in the look or feel of the area surrounding the implant greater than one year after their initial surgical sites were fully healed, and on average eight to ten years after receiving textured implants.

Patients undergoing plastic surgery procedures, aesthetic or reconstructive, should be thoroughly informed of the potential risks and possible complications known to be associated with the procedure, and any device used in that procedure. In the very rare cases where a diagnosis of BIA-ALCL is made, surgical treatment is essential for the management of the disease. Some patients with more advanced disease may require further treatment such as chemotherapy.
https://www.plasticsurgery.org/for-medical-professionals/health-policy/bia-alcl-physician-resources

ALCL is rare…Most patients were diagnosed when they sought medical treatment for implant-related symptoms such as persistent seromas, capsular contractures, or peri-implant masses warranting breast implant revision operations. In each case, lymphoma cells were found in the effusion fluid (seroma) surrounding the implant, in the fibrous capsule, or within a peri-implant mass. Typically, there was no invasion beyond the fibrous capsule into the breast parenchyma. As of September 30, 2017, the FDA has received a total of 414 medical device reports (MDRs) of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL), including 9 deaths1. BIA-ALCL are counted for those with a confirmed pathology test, or ALK or CD30 biomarkers, or reported by health care professionals. There are 272 reports with data on surface information at the time of reporting. Of these, 242 were on textured implants and 30 on smooth implants. There are 413 reports with data on implant fill type. Of these, 234 reported the use of silicone gel-filled implants, and 179 reported the use of saline-filled implants.
https://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/BreastImplants/ucm481899.htm

According to the Food and Drug Administration (FDA): Breast implants are medical devices that are implanted under the breast tissue or under the chest muscle to increase breast size (augmentation) or to rebuild breast tissue after mastectomy or other damage to the breast (reconstruction). They are also used in revision surgeries, which correct or improve the result of an original surgery. There are two types of breast implants approved for sale in the United States: saline-filled and silicone gel-filled.

There are two basic types of breast implants for sale in the United States: saline and silicone gel. Both types have a silicone outer shell. They vary in size, shell thickness, shell surface texture, and shape (contour). Saline breast implants are filled with sterile salt water. Should the implant shell leak, a saline implant will collapse, and the saline will be absorbed and naturally expelled by the body. Saline breast implants provide a uniform shape, firmness and feel, and are FDA-approved for augmentation in women age 18 or older. Silicone breast implants are filled with silicone gel. The gel feels a bit more like natural breast tissue. If the implant leaks, the gel may remain within the implant shell, or may escape into the breast implant pocket. A leaking implant filled with silicone gel will not collapse. If you choose silicone implants, you may need to visit your plastic surgeon regularly to make sure the implants are functioning properly. An ultrasound or MRI screening can assess the condition of breast implants. Silicone breast implants are FDA-approved for augmentation in women age 22 or older. https://www.plasticsurgery.org/cosmetic-procedures/breast-augmentation/implants

Round breast implants have a tendency to make breasts appear fuller than form-stable implants. Higher profile options can achieve even more projection. Because round implants are the same shape all over, there is less concern about them rotating out of place. Smooth breast implants are the softest feeling. They can move with the breast implant pocket, which may give more natural movement. Smooth implants may have some palpable or visible rippling under the skin. Textured breast implants develop scar tissue to stick to the implant, making them less likely to move around inside of the breast and become repositioned. Texturing offers some advantage in diminishing the risk of a tight scar capsule.

https://www.plasticsurgery.org/cosmetic-procedures/breast-augmentation/implants

There are two main types of breast implants: smooth surfaced and textured. Texturing is required for anatomically shaped implants to stop them rotating. No confirmed cases of ALCL have been reported with round, smooth surface prostheses. The lymphoma seems exclusively associated with textured prostheses, and the risk is highest for more robustly textured or polyurethane covered implants. https://www.bmj.com/content/363/bmj.k5054

Smooth breast implants are covered by a smooth outer shell while textured breast implants are covered by a grained outer shell.

According to the American Society of Plastic Surgeons, Breast implants are FDA-approved and safe devices that offer many quality-of-life benefits for women. Hundreds of thousands of patients each year opt for breast implants and report no adverse effects. When a possible association with a rare disease is reported, plastic surgeons follow the science to provide detailed, accurate information for full patient consent and decision making.

Breast implants are among the most studied medical devices in the world, and they will continue to be. Collaboration among the scientific community, patient advocacy groups and governments from around the world will continue to enhance the device and ensure the global plastic surgery community works together to keep all parties educated about the latest news and advancements to improve patient safety.

As noted, breast implants have been studied worldwide for decades, and the scientific literature shows no causal relationship between the device and autoimmune diseases. That’s not to say a patient could not have a negative reaction to any medical device, and if a woman desires to have her breast implants removed – for any reason – she should consult her plastic surgeon.

Breast implants remain an important option for breast reconstruction and augmentation. Like any medical device, breast implants carry a risk of complications, and in the event any complication develops, patients should consult their plastic surgeon to address it in a timely manner.

Patients considering breast implants should seek out a board-certified plastic surgeon to help weigh the benefits and potential risks to make the best possible decision.

BIA-ALCL: Breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) is a rare and highly treatable type of lymphoma that can develop around breast implants. Data show BIA-ALCL occurs most frequently in patients who have breast implants with textured surfaces. The current lifetime risk of BIA-ALCL is estimated to be 1:3817 – 1:30,000 for women with textured implants based upon current confirmed cases and textured implant sales data over the past two decades. Since the initial case report in 1996, ASPS now recognize approximately 265 cases in the US and a total of 673 worldwide as of January 25, 2019.

Most patients with BIA-ALCL have an excellent prognosis following surgical removal of the breast implants and the surrounding scar tissue capsule. Continued follow-up after any breast implant surgery is suggested and important for patient health, but patients who notice pain, lumps, swelling, fluid collections or unexpected changes in breast shape, including asymmetry, should contact their plastic surgeon. In most cases, women diagnosed with BIA-ALCL observed changes in the look or feel of the area surrounding the implant greater than one year after their initial surgical sites were fully healed, and on average eight to ten years after receiving textured implants. https://www.plasticsurgery.org/patient-safety/breast-implant-safety

Know the Facts

According to the FDA, if you are considering breast implants, here are five tips:
Recognize that breast implants are not considered lifetime devices.The longer people have them, the greater the chances are that they will develop complications, some of which will require more surgery. The life of breast implants varies by person and can’t be predicted. That means everyone with breast implants will face additional surgeries—but no one can tell them when. And while a few people may keep their original implants for 20 to 30 years, that is not the common experience.Patients can also request additional surgeries to modify the aesthetic outcome, such as size or shape.

Review product labeling.The FDA advises that people look at the Summary of Safety and Effectiveness Data (SSED) for each implant to learn about their characteristics and the fillers used. SSEDs have been produced for all approved saline and silicone gel-filled breast implants. These summaries provide information on the indications for use, risks, warnings, precautions, and studies associated with FDA approval of the device. They also provide information on how often serious complications occurred. The most serious complications are those that lead to further surgeries, such as ruptures or capsular contracture.

The FDA advises health care providers to give people the full product labeling—all of the patient information from the manufacturer—for implants. Ask your surgeon for the most recent version of the labeling and read it carefully. If you have questions about any of these documents, talk to your surgeon.

Communicate with your surgeon.Surgeons must evaluate the shape, size, surface texture, and placement of the implant and the incision site for each person. Ask the surgeon questions about his or her experience in performing breast implant surgery, the surgical procedure, and the ways the implant might affect your life.

Also, tell the surgeon about previous surgeries and your body’s response—for example, whether surgeries resulted in a larger than expected amount of scar tissue—and discuss your expectations. This discussion helps the surgeon make operative decisions that achieve the desired appearance, including decisions about incision location and size as well as implant size, material, and placement. Many people have additional operations to change implant size. To achieve the best results after the first procedure, careful planning and reasonable expectations are necessary.

Learn about long-term risks.The FDA has identified an association between breast implants and the development of anaplastic large cell lymphoma (ALCL), a type of non-Hodgkin’s lymphoma. People who have breast implants may have an increased risk of developing ALCL in the fluid or scar tissue surrounding the implant. Breast implants approved in the U.S. can be filled with either saline or with silicone gel. They come in different sizes and shapes and have either smooth or textured surfaces (shells). BIA-ALCL appears to develop more frequently in individuals with textured implants than in people with smooth-surfaced implants. Remember, like other lymphomas, ALCL is a cancer of the immune system and not of breast tissue.

Although some women with implants may have experienced health problems such as connective tissue diseases (such as lupus and rheumatoid arthritis), trouble breastfeeding, or reproductive problems, current evidence does not support an association between breast implants and these conditions.

Know that monitoring is important.In general, follow your health care provider’s instructions on how to monitor your breast implants.

If you notice any unusual signs or symptoms, report these changes promptly to your health care provider. Also, follow your health care provider’s instructions for how to monitor your breast implants and for routine mammography screening for breast cancer. When you make your appointment, make sure to inform the mammography facility that you have breast implants so enough time is scheduled for your mammogram. Your health care provider may also recommend other tests, such as magnetic resonance imaging (MRI). The FDA recommends that people with silicone implants get MRI screenings to detect silent ruptures three years after their surgery and every two years after that.https://www.fda.gov/ForConsumers/ConsumerUpdates/ucm338144.htm

Know the Risks

FDA-approved implants undergo extensive testing to establish reasonable assurance of safety and effectiveness.Nonetheless, there are risks associated with all breast implants, including:
• additional surgeries
• breast implant associated-anaplastic large cell lymphoma (BIA-ALCL), a cancer of the infection-fighting cells (lymphocytes) of the immune system
• capsular contracture, which is scar tissue that squeezes the implant
• breast pain
• rupture (tears or holes in the shell) with deflation of saline and silicone gel-filled implants
• silent (without symptoms) rupture of silicone gel-filled implants
• infection

Note: The silicone used for breast implants is different than injectable silicone. Injectable silicone is not FDA approved for body contouring.

Whatever your age, relationship status, sexual activity, or orientation, you can’t predict how you will react to losing a breast. It’s normal to feel anxious, uncertain, sad, and mournful about giving up a part of your body that was one of the hallmarks of becoming a woman: a significant part of your sexuality, what made you look good in clothes, how you might have fed your babies. No one can ever take that away from you. Moving forward, you now have the opportunity to determine what you want to have happen next. But first you must do some careful thinking and delving into your feelings in order to figure out what is best for you. In this section, we’ll talk you through each of the reconstruction options, what’s involved, and any risks, as well as alternatives to reconstruction.

Asking yourself some questions can help you start to think about what type of reconstruction you want — if you want reconstruction at all:
• How important is rebuilding your breast to you?
• Can you live with a breast form that you take off and put on?
• Will breast reconstruction help you to feel whole again?
• Are you OK with having more surgery for breast reconstruction after mastectomy or lumpectomy?

It’s also important to know that while breast reconstruction rebuilds the shape of the breast, it doesn’t restore sensation to the breast or the nipple. Over time, the skin over the reconstructed breast can become more sensitive to touch, but it won’t be exactly the same as it was before surgery.https://www.breastcancer.org/treatment/surgery/reconstruction

If you have a breast implant…don’t hesitate to call your doctor if you’re concerned. Definitelycall your doctor if you have symptoms or problems with your implant, such as pain, lumps, swelling, or asymmetry, especially if these problems develop years after the implant was placed.

If you are considering breast reconstruction with an implant, talk to your doctor about the risks and benefits of implants, including the differences between textured and smooth implants.

Still, there are two questions that don’t have good answers:
• Does it make sense to leave an implant with no problems in place if the opposite breast had an implant and tissue capsule removed because of BIA-ALCL?
• Is it safe to replace an implant removed because of BIA-ALCL with a new implant?

More research is needed to address these issues.

It’s important to know that the FDA emphasized that the risk of ALCL in women with breast implants is extremely low. The FDA doesn’t think that the link should discourage women from implant reconstruction.

https://www.breastcancer.org/research-news/study-estimates-risk-of-rare-cancer-from-implants

The first textured implant was produced in 1968 based on a design from plastic surgeon W. Pangman and was known as the “Natural Y” implant, so named because it consisted of three internal compartments which were meant to retain the shape of the upper aspect of the implant. It was essentially a regular, smooth-surfaced silicone implant with a polyurethane foam coating of 1.5–2 mm on its surface.

In terms of textured surfaces, the Biocell surface results from a “salt-loss technique.” After the mandrel is coated in silicone and before the implant surface is cured, an additional step is introduced into the standard protocol. To produce a textured-surface implant, some manufacturers (Allergan, Inc.) introduce an additional step into the standard protocol, during which a silicone-coated mandrel is pushed into granular salt before being allowed to cure in the laminar flow oven. Once the surface has cured, this salt is then removed by washing the surface of the implant in water, but the implant surface remains pitted with randomly-arranged, cubed indentations.
https://academic.oup.com/asj/article/31/1/56/273842

Studies have noted that to date, when the implant type has been identified, ALCL has been found more frequently in association with breast implants having a textured outer shell rather than a smooth outer shell. http://wayback.archive-it.org/7993/20171115053750/https://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/BreastImplants/ucm239996.htm

Data suggest that BIA-ALCL occurs more frequently in individuals with textured breast implants, though more work needs to be done to understand the risk factors for the disease.BIA-ALCL appears to develop more frequently in individuals with textured implants than in people with smooth-surfaced implants. Before getting breast implants, make sure to talk to your health care provider about the benefits and risks of both textured-surface and smooth-surfaced implants.

The goal of breast implant removal surgery is to remove breast implants from breast augmentation or breast reconstruction patients. During these procedures, the surgeon may also remove silicone material from implant leaks and the breast capsule, which is the scar tissue that forms after the placement of a breast implant.

Often, the scar tissue that forms after the placement of an implant is soft and does not need to be removed, but it may harden, causing pain and discomfort. This is often a reason to have the implants and scar tissue removed.

Breast implants are not lifelong devices and it is important to have them exchanged or removed approximately every 10-15 years. This decision is typically based on the individual and the patient’s needs and desires.

In some cases, the outside shell of the implant breaks down causing silicone to leak and the scar tissue around the implant to harden. It is important to understand that your implants should be removed for this reason.

Breast implant removal surgery is a highly individualized procedure. It should be performed if you have capsular contracture (hardening of the breast), pain with implants, imaging has shown a leak of the capsule and/or if you no longer desire implants or wish to exchange them.

In general, you may be a good candidate for breast implant removal if:
• You are physically healthy and at a stable weight
• You have realistic expectations
• You are a nonsmoker
• You are bothered by the appearance of your implants
• You have experienced discomfort or pain
• You feel your breasts are too heavy
• You are starting to feel your breast scar tissue is getting harder or tighter
• Imaging suggests a leak or rupture of implants
• You have experienced a rupture or leak of implants

If you’re considering surgery, spend some time reviewing before and after photos and learning about what to expect during recovery. Preparation ahead of time helps patients have reasonable expectations and a smoother recovery.

The average cost of breast implant removal surgery is $2,357, according to 2017 statistics from the American Society of Plastic Surgeons.

Breast implant removal costs can widely vary. The average fee referenced above is only part of the total cost – it does not include anesthesia, operating room facilities or other related expenses.

A surgeon’s fee for breast implant removal will be based on his or her experience, the type of procedure used and the geographic office location.

Many plastic surgeons offer patient financing plans for breast implant removal in instances where health insurance does not cover it, so be sure to ask.

Breast implant removal costs may include:
• Surgeon’s fee
• Hospital or surgical facility costs
• Anesthesia fees
• Prescriptions for medication
• Post-surgery garments
• Medical tests and x-rays

When choosing a board-certified plastic surgeon for breast implant removal surgery, remember that the surgeon’s experience and your comfort with the physician are just as important as the final cost of the surgery.

During your breast implant removal consultation, be prepared to discuss:
• Your surgical goals
• Medical conditions, drug allergies and medical treatments
• Current medications, vitamins, herbal supplements, alcohol, tobacco and drug use
• Previous surgeries

Your plastic surgeon will also:
• Evaluate your general health status and any pre-existing health conditions or risk factors
• Examine your breasts
• Take photographs
• Discuss your options and recommend a course of treatment
• Discuss likely outcomes of breast implant removal surgery and any risks or potential complications

The success and safety of your breast implant removal procedure depend very much on your complete candidness during your consultation. You’ll be asked a number of questions about your health, desires and lifestyle.

Be sure to ask your plastic surgeon questions. It’s very important to understand all aspects of your breast implant removal surgery. To help, we have prepared a checklist of questions to ask your plastic surgeon that you can take with you to your consultation.

It’s natural to feel some anxiety. Don’t be shy about discussing these feelings with your plastic surgeon.

Use this checklist as a guide during your breast implant removal consultation:
• Are you certified by the American Board of Plastic Surgery?
• Were you trained specifically in the field of plastic surgery?
• What specific training do you have in breast implant revision techniques?
• How many years of plastic surgery training have you had?
• Do you have hospital privileges to perform this procedure? If so, at which hospitals?
• Is the office-based surgical facility accredited by a nationally- or state-recognized accrediting agency, or is it state-licensed or Medicare-certified?
• Am I a good candidate for this procedure?
• What will be expected of me to get the best results?
• Where and how will you perform my procedure?
• What surgical technique is recommended for me?
• How long of a recovery period can I expect, and what kind of help will I need during my recovery?
• What are the risks and complications associated with my procedure?
• How are complications handled?
• How can I expect my breast implant removal procedure to look over time?
• What are my options if I am dissatisfied with the outcome?
• Do you have before-and-after photos I can look at for this procedure and what results are reasonable for me?

The decision to have breast implant removal surgery is dependent on many factors, including your overall health, if the implant is leaking, if the implant has ruptured and your personal desire. You’ll have to decide if the benefits will achieve your goals and if the risks and potential complications of breast implant removal are acceptable.

Your plastic surgeon and/or staff will explain in detail the risks associated with surgery. You will be asked to sign consent forms to ensure that you fully understand the procedures you will undergo and any risks or potential complications.

The possible risks of breast implant removal surgery include, but are not limited to:
• Bleeding
• Infection
• Poor healing of incisions
• Hematoma
• Anesthesia risks
• Fluid accumulation (seroma)
• Skin loss
• Numbness or other changes in skin sensation
• Numbness or other changes in nipple/areola sensation
• Skin discoloration and/or prolonged swelling
• Unfavorable scarring
• Recurrent looseness of skin
• Fatty tissue found deep in the skin might die (fat necrosis)
• Deep vein thrombosis, cardiac and pulmonary complications
• Asymmetry
• Suboptimal aesthetic result
• Possibility of revision surgery
• Persistent pain
• Scarring

These risks and others will be fully discussed prior to your consent. It’s important that you address all your questions directly with your plastic surgeon.
https://www.plasticsurgery.org/cosmetic-procedures/breast-implant-removal/safety

According to the National Center for Health Research, “Since 2015, the National Center for Health Research has been contacted by more than 4,500 women who had breast implants that they wanted to remove because of rupture, breast pain, or medical symptoms that they believed to be related to their implants. Most of the women could not afford explant surgery and asked for NCHR’s assistance in persuading their health insurance, Medicare, or Medicaid to cover the cost of implant removal without replacement. NCHR has a project to assist these women if they have insurance but have had difficulty getting coverage for explant surgery. Most health insurance policies will cover the cost of breast implant removal when it meets the policy’s criteria for medical necessity. In almost all cases, medical necessity is defined as a leaking silicone gel breast implant or severe capsular contracture that causes breast hardness and pain. We are not aware of any policies that will cover removal due to systemic illnesses caused by implants, such as those described by thousands of women with breast implants. However, in many cases women have systemic illness in addition to having capsular contracture and a leaking silicone gel implant.”

http://www.center4research.org/breast-implant-illnesses-whats-evidence/

Per the FDA, below are some things the FDA thinks you should consider before undergoing breast augmentation, reconstruction or revision (replacement) surgery.
• Breast implants are not lifetime devices, the longer you have your implants, the more likely it will be for you to have them removed.
• The longer you have breast implants, the more likely you are to experience local complications and adverse outcomes.
• The most common local complications and advere outcomes are capsular contracture, reoperation and implant removal. Other complications include rupture or deflation, wrinkling, asymmetry, scarring, pain, and infection at the incision site.
• You should assume that you will need to have additional surgeries (reoperations).
• Many of the changes to your breast following implantation may be cosmetically undesirable and irreversible.
• If you have your implants removed but not replaced, you may experience changes to your natural breasts such as dimpling, puckering, wrinkling, breast tissue loss, or other undesirable cosmetic changes.
• If you have breast implants, you will need to monitor your breasts for the rest of your life. If you notice any abnormal changes in your breasts, you will need to see a doctor promptly.
• If you have silicone gel-filled breast implants, you will need to undergo periodic MRI examinations in order to detect ruptures that do not cause symptoms (“silent ruptures”). For early detection of silent rupture, the FDA recommends that women with silicone gel-filled breast implants receive MRI screenings 3 years after they receive a new implant and every 2 years after that. MRI screening for implant rupture is costly and may not be covered by your insurance.
• If you have breast implants, you have a risk of developing a type of cancer called breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) in the breast tissue surrounding the implant. BIA-ALCL is not breast cancer. Women diagnosed with BIA-ALCL may need to be treated with surgery, chemotherapy and/or radiation therapy.

According to the American Society of Plastic Surgeons, below are a few of the reasons a follow-up procedure may be necessary after receiving breast implants.

Rupture or deflation: Exceedingly rare in both saline and silicone implants. If it does occur, however, a revision will be necessary.

Development of capsule contracture: If scar tissue forms around your breast, it can harden and change position and/or shape. In these instances, another procedure to replace the implants can alleviate the issue.

Dissatisfaction with initial results, or a desired change in breast size.

The goal of breast implant revision surgery is to replace old breast implants with new implants. Often the goal is also to change or improve the appearance of the breasts while updating the implant material, which could include:
• A concurrent breast lift or reduction
• Reshaping the breast implant pocket to reposition the implant on the chest
• Either increasing or decreasing the size, shape or style of the breast implant

The desire to have breast implant revision surgery can be because of any of the following reasons:
• Desire to change the size of the breasts
• Pain from capsular contracture
• Concern about rupture or migration of implant
• Change from saline to silicone or different style of implant

Over time, breast implants can change shape or size, and the overlying breast tissue can also change, creating an appearance or feel to the breast that is less desirable than the original result. Also, many breast implants have a lifetime warranty on the actual implant device, but after ten years the costs associated with having surgery to replace the implants are no longer covered. Because of this, many women will elect to replace or update their breast implants at or around the 10-year time frame.

Breast implant revision surgery is not a standard or routine procedure and needs to be tailored specifically to the patient’s goals and desires. Therefore, this surgery should be performed by a board-certified plastic surgeon who is well-trained and experienced in all types of breast surgery and who will listen to the patient’s goals and desires and will develop a surgical plan specifically to address all of the issues at the time of surgery.
https://www.plasticsurgery.org/news/blog/will-you-need-to-replace-your-breast-implants

Breast implant revision surgery is intended for patients who have had a breast augmentation in the past and are now unhappy with their implants or concerned about the condition of their implants. This procedure can address those concerns by replacing the existing implants with new implants.

In general, you may be a good breast implant revision candidate if:
• You are unhappy with size, shape or appearance of your breast implants
• You are concerned about the integrity or condition of your implants
• You are physically healthy and at a stable weight
• You have realistic expectations
• You are a nonsmoker

If you’re considering surgery, spend some time reviewing breast implant revision surgery photos and learning about what to expect during recovery. Preparation ahead of time helps patients have reasonable expectations and a smoother recovery.

A plastic surgeon’s cost for breast implant revision surgery may vary based on his or her experience as well as geographic location. In some instances, health insurance may cover breast implant revision surgery. Also, in some instances, the implant warranty will cover some of the costs associated with this surgery.

Many plastic surgeons offer patient financing plans for breast implant revision surgery in instances where health insurance does not cover it, so be sure to ask.

Breast implant revision costs may include:
• Surgeon’s fee
• Hospital or surgical facility costs
• Implant costs
• Anesthesia fees
• Prescriptions for medication
• Post-surgery garments
• Medical tests and x-rays

When choosing a board-certified plastic surgeon for breast implant revision surgery, remember that the surgeon’s experience and your comfort with him or her are just as important as the final cost of the surgery.

During your breast implant revision consultation, be prepared to discuss:
• Your surgical goals
• Medical conditions, drug allergies and medical treatments
• Current medications, vitamins, herbal supplements, alcohol, tobacco and drug use
• Previous surgeries

Your plastic surgeon will also:
• Evaluate your general health status and any pre-existing health conditions or risk factors
• Examine your existing breast implants
• Take photographs
• Discuss your options and recommend a course of treatment
• Discuss likely outcomes of breast implant revision surgery and any risks or potential complications

The success and safety of your breast implant revision procedure depends very much on your complete candidness during your consultation. You’ll be asked a number of questions about your health, desires and lifestyle.

Be sure to ask your plastic surgeon questions. It’s very important to understand all aspects of your breast implant revision surgery. To help, we have prepared a checklist of questions to ask your plastic surgeon that you can take with you to your consultation.

It’s natural to feel some anxiety, whether it’s excitement or a bit of preoperative stress. Don’t be shy about discussing these feelings with your plastic surgeon.

Use this checklist as a guide during your breast implant revision consultation:
• Are you certified by the American Board of Plastic Surgery?
• Were you trained specifically in the field of plastic surgery?
• What specific training do you have in breast implant revision techniques?
• How many years of plastic surgery training have you had?
• Do you have hospital privileges to perform this procedure? If so, at which hospitals?
• Is the office-based surgical facility accredited by a nationally- or state-recognized accrediting agency, or is it state-licensed or Medicare-certified?
• Am I a good candidate for this procedure?
• What will be expected of me to get the best results?
• Where and how will you perform my procedure?
• What surgical technique is recommended for me?
• How long of a recovery period can I expect, and what kind of help will I need during my recovery?
• What are the risks and complications associated with my procedure?
• How are complications handled?
• How can I expect my breast implant revision to look over time?
• What are my options if I am dissatisfied with the outcome?
• Do you have before-and-after photos I can look at for this procedure and what results are reasonable for me?

Your plastic surgeon and/or staff will explain in detail the risks associated with surgery. You will be asked to sign consent forms to ensure that you fully understand the procedures you will undergo and any risks or potential complications.

The possible risks of breast implant revision surgery include, but are not limited to:
• Bleeding
• Infection
• Poor healing of incisions
• Hematoma
• Anesthesia risks
• Fluid accumulation (seroma)
• Skin loss
• Numbness or other changes in skin sensation
• Skin discoloration and/or prolonged swelling
• Unfavorable scarring

These risks and others will be fully discussed prior to your consent. It’s important that you address all your questions directly with your plastic surgeon.

https://www.plasticsurgery.org/cosmetic-procedures/breast-implant-revision
• Recurrent looseness of skin
• Fatty tissue found deep in the skin might die (fat necrosis)
• Deep vein thrombosis, cardiac and pulmonary complications
• Asymmetry
• Suboptimal aesthetic result
• Possible need for revision surgery
• Persistent pain